Hitachi C41V1 Manual de usuario
C41V1 Probe
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1432-7
© Hitachi, Ltd. 2013,2017. All rights reserved.
Notes for operators and responsible maintenance personnel
★ Please read through this Instruction Manual carefully prior to use.
★ Keep this Instruction Manual together with the system with care to
make it available anytime.
0123
( 1 ) Q1E-EP1432
Manufacturer: Hitachi, Ltd.
2-16-1, Higashi-Ueno, Taito-ku, Tokyo,110-0015,
Japan
+81-3-6284-3668
http://www.hitachi.com/businesses/healthcare/
index.html
European
Representative: Hitachi Medical Systems GmbH
Otto-von-Guericke-Ring 3 D-65205 Wiesbaden,
Germany
EU Importer: Hitachi Medical Systems Europe Holding AG
Address: Sumpfstrasse 13 CH-6300 Zug, Switzerland
Local Distributor:
( 2 ) Q1E-EP1432
About this manual
This instruction manual contains safety precautions, the inspection,
the operation procedure and the reprocessing procedure of C41V1 Probe.
Please read this manual thoroughly to ensure the safety operation.
If you have any questions concerning the operation of the probe, please
contact a service support.
The following conventions are used throughout the manual to denote
information of special emphasis.
WARNING: “Warning” indicates the presence of a hazard which may
result in severe personal injury, substantial property
damage, or death if the warning is ignored.
CAUTION: “Caution” indicates the presence of a hazard which will or
can cause minor personal injury or property damage if the
caution is ignored.
NOTICE: “Notice” indicates information of installation, operation,
or maintenance, which is important, but not hazard related.
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Graphical Symbols for Use in Labeling of Hitachi Ultrasound Probes
Some graphical symbols that are used in labeling of Hitachi Ultrasound Probes are
compliant with EN980:2008 standard. Refer to the following table about the meanings
of them.
Explanation of Symbol Symbol Descriptive Content
Manufacturer Company
Name and Address
Hitachi, Ltd.
2-16-1, Higashi-Ueno, Taito-ku,
Tokyo, 110-0015, Japan
+81-3-6284-3668
http://www.hitachi.com/businesses/
healthcare/index.html
Authorized
Representative
in The European
Community
Hitachi Medical Systems GmbH
Otto-von-Guericke-Ring 3 D-65205
Wiesbaden, Germany
Keep away
from Sunlight
Store the probe in a cool place and keep
away from high temperature, high
humidity, or direct sunlight.
Contains or presence of
natural rubber latex
Contains or presence of natural rubber
latex
Do not re-sterilize
Do not re-sterilize
Do not reuse
Do not reuse
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Definition of symbol
The following symbol is also used for HITACHI Ultrasound Probes.
Location Symbol Definition
Probe connector
This instrument complies with
Directive 93/42/EEC relating to
Medical Device and Directive
2011/65/EU relating to RoHS
Probe connector IPX7 IPX7 mark
See section 1.6.
Probe connector Type BF APPLIED PART
Probe connector General warning sign
Probe connector Warning; dangerous voltage
Probe connector Caution; Biohazard
Probe connector
Follow the instruction manual to
operate this instrument. If not
avoided, may result in injury, property
damage, or the equipment trouble.
Probe connector
STERRAD sterilization compatibility
mark
Probe connector Do not waste the instrument as general
waste. Comply with a local regulation.
Probe connector Rx Only
By prescription only. U.S. Federal Law
restricts this device to sale on order
of a physician only.
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CONTENTS
Page
1. Introduction ................................................. 1
1.1 Features ......................................................... 1
1.2 Principles of operation .......................................... 1
1.3 Intended Use ..................................................... 2
1.4 Components ....................................................... 2
1.5 Accessories (Option) ............................................. 3
1.6 Construction ..................................................... 4
2. Inspection before Use ........................................ 5
2.1 Inspection for Appropriate Connection ............................ 5
2.2 Inspection for Material Surface .................................. 5
3. Operation Procedure .......................................... 6
3.1 Connection and Settings .......................................... 6
3.2 How to attach the Sterile Puncture Adapter (EZU-PA7V) ............ 8
3.3 Display of Needle Guide Line ..................................... 9
4. Option of C41V1 Probe ....................................... 11
4.1 Magnetic sensor ................................................. 11
5. Cleaning, Disinfection and Sterilization .................... 13
5.1 Point of use (Pre-cleaning) ..................................... 16
5.2 Containment and transportation .................................. 17
5.3 Manual Cleaning and disinfection ................................ 17
5.4 Drying .......................................................... 21
5.5 Inspection ...................................................... 21
5.6 Packaging ....................................................... 22
5.7 Sterilization ................................................... 23
5.8 Storage ......................................................... 25
6. Maintenance and Safety Inspection ........................... 26
6.1 Daily Inspection ................................................ 26
6.2 Store ........................................................... 26
7. Safety Precautions .......................................... 27
8. Specifications .............................................. 29
8.1 Probe ........................................................... 29
8.2 Sterile Puncture Adapter EZU-PA7V ............................... 30
8.3 Suppliers List .................................................. 31
9. Disposal of the probe ....................................... 31
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1. Introduction
1.1 Features
C41V1 Probe is a Convex Array Probe.
The acoustic output of this probe when connected to ultrasound
diagnostic scanner was measured according to the IEC60601-2-37
standard. The table of measured acoustic output data is contained
in the operational manual of each ultrasound diagnostic scanner.
This probe is categorized in class IIa according to Directive
93/42/EEC.
According to IEC60601-1 the probe is classified as type BF.
1.2 Principles of operation
This probe and the ultrasound diagnostic scanner enable image
diagnosis using ultrasonic waves. This system operates under the
principles described below.
1) When an electric pulse signal is applied from the transmitter
to the transducer of the probe, the transducer converts electric
signals into mechanical vibration energy for emitting
pulse-shaped ultrasonic waves into the body part, liquid or
other medium contacting the transducer.
2) The emitted ultrasonic waves are reflected by boundaries with
different acoustic characteristics (acoustic impedance) within
the body.
3) The transducer is also used to receive reflected ultrasonic
waves. The transducer vibrates mechanically due to the received
ultrasonic waves and converts mechanical vibrations into
electric energy. Electric signals are converted to shades of
brightness by brightness modulation to obtain an image.
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1.3 Intended Use
C41V1 Probe is designed for observation and diagnosis of the
following regions mainly by connecting with the HITACHI ultrasound
diagnostic scanner.
General OB/GYN organs
Biopsy (with a Sterile Puncture Adapter)
Transvaginal/Transrectal
Never use the probe for following regions.
1) The heart (Do not contact directly)
2) The eyeball
1.4 Components
Components of C41V1 Probe are as follows:
1) Probe ............................... 1 piece
2) Instruction Manual .................. 1 copy
The probe is not sterilized when delivered. Prior to use, be sure
to clean, disinfect and sterilize it.
WARNING
C
A
U
TI
O
N
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CAUTION
1.5 Accessories (Option)
1.5.1 Sterile Puncture Adapter EZU-PA7V (Disposable)
EZU-PA7V is the attachment for ultrasound guided transvaginal
or transrectal biopsy and aspiration of organs, cyst and tumor.
The size of needles available is 16 to 19G. Biopsy application
requires special care. 24 pieces of Sterile Puncture Adapter
EZU-PA7V are packaged in one set as follows:
Component Model Note
Sterile Puncture Adapter EZU-PA7V 24 pcs
NOTE: If you need Sterile Puncture Adapters, please contact a service
support.
A well-trained physician only should perform a biopsy.
1.5.2 Probe cover for Single Use (Disposable)
To protect the probe against contamination, using probe cover
is recommended. If using probe cover, lubrication free or dry
type probe cover is recommended.
Lubrication may cause a deterioration of the probe surface.
Use of non-allergic probe cover is strongly recommended to
avoid allergic reactions due to latex rubber.
Discard the used probe cover carefully.
1.5.3 Magnetic Sensor Attachment
Magnetic Sensor Attachment is needed for Real-time Virtual
Sonography (RVS). It is used to fix the magnetic sensor to the
probe.
The Magnetic Sensor Attachment is not sterilized when delivered from
the factory. Prior to use, be sure to clean, disinfect and sterilize
it.
C
A
U
TI
O
N
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1.6 Construction
The external view of C41V1 Probe is shown in Fig.1.
Immersible part: This part can be immersed in disinfectant solution
and also can be cleaned by water.
Un-immersible part: This part should not be immersed in disinfectant
solution and also can not be cleaned by water.
Fig.1
E
xternal view
C
able
Connector
U
n
-
i
mmer
s
ible
p
art
Immersible part (IP
X
7
)
Applied part
Magnetic sensor attachment (Option)
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